Section 11-850-116 - Processes and controls(a) General. (1) All operations in the production and storage of cannabis, manufactured cannabis products, and components shall be conducted in accordance with adequate sanitation principles.(2) Appropriate quality control operations shall be employed to ensure that cannabis and manufactured cannabis products are suitable for human consumption or for topical application to the skin or hair, as applicable, and that packaging materials are safe and suitable.(3) Overall sanitation of the facility shall be under the supervision of one or more competent individuals assigned responsibility for this function.(4) Adequate precautions shall be taken to ensure that production procedures do not contribute to allergen cross-contact or to contamination from any source.(5) Chemical, microbial, or extraneous-material testing procedures shall be used where necessary to identify sanitation failures or possible allergen cross-contact and contamination.(6) All cannabis, components, and in-process materials that have become contaminated shall be rejected, or if appropriate and allowed under section 11-850-135(h) (1), treated or processed to eliminate the contamination.(b) Ingredients. (1) Ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into manufactured cannabis products and shall be stored under conditions that will protect against allergen cross-contact and against contamination and minimize deterioration. Ingredients shall be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying cannabis, manufactured cannabis products, or components shall be safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying cannabis, manufactured cannabis products, or components if it does not cause allergen cross-contact or increase the level of contamination of the cannabis, manufactured cannabis product, or component.(2) Ingredients shall either not contain levels of microorganisms that may render the manufactured cannabis product injurious to the health of humans, or they shall be treated during manufacturing operations so that they no longer contain levels that would cause the product to be contaminated.(3) Ingredients susceptible to contamination with aflatoxins or other natural toxins shall not be contaminated before these ingredients are incorporated into a manufactured cannabis product.(4) Ingredients and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material shall be examined and, based on examination results, shall not be contaminated before these ingredients are incorporated into a manufactured cannabis product.(5) Ingredients and rework shall be stored in bulk or in containers designed and constructed so as to protect against mix-ups, allergen cross-contact, and contamination and shall be stored at such temperature and relative humidity and in such a manner as to prevent the ingredients or manufactured cannabis product from becoming contaminated. Material scheduled for reprocessing shall be identified as such.(6) Frozen ingredients shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents the ingredients from becoming contaminated.(7) Liquid or dry ingredients received and stored in bulk form shall be stored in a manner that protects against allergen cross-contact and against contamination.(8) Ingredients that are allergens, and rework that contains allergens, shall be identified and stored in a manner that prevents allergen cross-contact.(9) Water used as an ingredient shall be: (A) Of a defined quality;(B) Unaffected by materials used in the water treatment equipment;(C) Tested or monitored regularly to verify that it meets applicable chemical, physical, and microbiological specifications for quality; and(D) Supplied by a system set up to avoid stagnation and risks of contamination that is routinely cleaned and sanitized according to an appropriate standard operating procedure that ensures no biofilm build-up.(c) Manufacturing operations. (1) Equipment, utensils, and containers shall be maintained in an adequate condition through appropriate cleaning and sanitizing, as necessary. Insofar as necessary, equipment shall be taken apart for thorough cleaning.(2) All cannabis and manufactured cannabis product production and storage shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, allergen cross-contact, contamination, and deterioration.(3) Components that can support the rapid growth of undesirable microorganisms shall be stored at temperatures that will prevent the component from becoming contaminated during production and storage.(4) Measures such as sterilizing, irradiating, pasteurizing, cooking, freezing, refrigerating, controlling pH, or controlling aw that are taken to destroy or prevent the growth of undesirable microorganisms shall be adequate under the conditions of production, storage, and distribution to prevent cannabis, manufactured cannabis products, or components from being contaminated.(5) Work-in-process and rework shall be handled in a manner that protects against allergen cross-contact, contamination, and growth of undesirable microorganisms.(6) Effective measures shall be taken to protect cannabis and manufactured cannabis products from allergen cross-contact and from contamination by ingredients, other components, or refuse. When ingredients, other components, or refuse are unprotected, they shall not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in allergen cross-contact or contamination of cannabis or manufactured cannabis products. Cannabis, manufactured cannabis products, or components transported by conveyor shall be protected against allergen cross-contact and against contamination as necessary.(7) Equipment, containers, and utensils used to convey or store cannabis, components, work-in-process, rework, or other manufactured cannabis products shall be constructed, handled, and maintained during production and storage in a manner that protects against allergen cross-contact and against contamination.(8) Adequate measures shall be taken to protect against the inclusion of metal or other extraneous material in cannabis or manufactured cannabis products.(9) Cannabis, manufactured cannabis products, and components that are contaminated:(A) Shall be disposed of in a manner that protects against the contamination of other cannabis, manufactured cannabis products, and components; or(B) If the contaminated cannabis, manufactured cannabis product, or component is allowed to be reprocessed under section 11-850-135(h)(1), it may be:(i) Reprocessed using a method that has been proven to be effective; or(ii) Reprocessed and reexamined and subsequently found not to be contaminated before being incorporated into other manufactured cannabis products.(10) All operations in the production and storage of cannabis, manufactured cannabis products, and components shall be performed so as to protect cannabis, manufactured cannabis products, and components against allergen cross-contact, contamination, and growth of undesirable microorganisms. Cannabis, manufactured cannabis products, and components shall be protected from contaminants that may drip, drain, or be drawn into them.(11) Heat blanching, when required in the preparation of manufactured cannabis products or components capable of supporting microbial growth, shall be effected by heating the manufactured cannabis product or component to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling it or passing it to subsequent manufacturing without delay. Growth and contamination by thermophilic microorganisms in blanchers shall be minimized by the use of adequate operating temperatures and by periodic cleaning and sanitizing as necessary.(12) Cannabis and manufactured cannabis products and components that rely principally on the control of aw for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level.(13) Manufactured cannabis products and components that rely principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below.(14) When ice is used in contact with cannabis, manufactured cannabis products, or components, it shall be made from water that is safe and of adequate sanitary quality in accordance with section 11-850-114(1) and manufactured in accordance with current good manufacturing practice.Haw. Code R. § 11-850-116
[Eff and comp 2/24/2022] (Auth: HRS §§ 321-9, 329D-9, 329D-27) (Imp: HRS § 329D-9)